Liver Failure, AcuteHERCOLENCT03312036
HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification
A study testing Coupled plasma filtration and adsorption (CPFA) in people with Liver Failure, Acute and Liver Failure, Acute on Chronic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Acute, Liver Failure, Acute on Chronic
- What is being tested?
- Coupled plasma filtration and adsorption (CPFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2013to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute liver failure
- Acute on chronic liver failure
- Bridge to liver transplantation
Who cannot join
- acute hemorrhage
- shock
- respiratory failure
- acute coronary syndrome
- psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital
Bologna
About this study
CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.
Read the detailed description
CPFA allows an improvement of blood pressure and inflammatory response during sepsis and multiorgan failure. This extracorporeal detoxification system was developed to non-specifically remove larger mediators during systemic inflammation with an extracorporeal circuit consisting of a plasma filter, a resin cartridge and a high-flux dialyzer. At present it is performed with the use of a five-pump modular treatment consisting of a plasma filter and a following absorption on an unselective hydrophobic resin cartridge and a final passage of the reconstituted blood through a high permeability polyethersulfone haemofilter, in which convective exchanges may be applied in a postdilution mode. Ronco et al. in 2002 compared CPFA treatment to continuous veno-venous haemodiafiltration (CVVHDF) in 10 patients affected by septic shock. The patients underwent 10-hour length CPFA and an increase of arterial blood pressure and a significant reduction of norepinephrine dosage were observed in comparison to the arterial blood pressure and the norepinephrine dosage achieved with the CVVHDF treatment. Formica et al. in 2004 confirmed these results using 100 CPFA treatments in 12 patients affected by septic shock with or without acute kidney injury. Patient survival at 28 days was 90%, while survival of after 90 days was 70%. Mao et al. also compared CPFA with High Volume Hemofiltration and they showed that CPFA increased the ratio between anti-inflammatory and pro-inflammatory cytokines; CPFA enhanced Human Leucocyte Antigen (HLA) class II expression on monocytes and improved the leukocyte response to inflammation measuring leukocyte production of Tumor Necrosis Factor-alfa. Recently Livigni et al. on behalf of the Italian group for the evaluation of interventions in intensive care medicine carried out a randomised controlled trial enrolled 330 adult patients with septic shock, 192 were randomised to either have CPFA added to the standard care, or not. CPFA was to be performed daily for 5 days, lasting at least 10 h/day. The trial was stopped because nearly 50% of the patients could not achieve treatment completion due to technical reasons (primarily coagulation). The trial did observe that patients with the highest amounts of treated plasma appeared to have a survival benefit. The technique underwent further modifications to improve the technical aspects and anticoagulation and a new trial is now underway with a high dose of plasma > 0.18 litres/ kg/ day.
As to the hepatic toxin removal it depends on the ability of the detoxification system to extract albumin bound toxins by means of adsorption. The adsorption consists in the consolidation on the surface of a solid material of molecules floating in a fluid after matching the fluid with the solid. The consolidation is due to weak bounds as in the case of Van der Waals and hydrophobic bounds. The selectivity of adsorption occurs when albumin molecules easily pass throughout the sorbent while the sorbent draw the albumin carried toxins into the pores of the sorbent. The hepatic toxins often are hydrophobic and with molecular weight < 1,000 daltons (bilirubin = 406 daltons, cholic acid = 283 daltons, chenodeoxycholic acid = 272 daltons). The albumin structure consists in 3 domains, which allows a multi-binding protein transport. As to bilirubin, its protein binding is a physiological protective mechanism to prevent the free bilirubin diffusion and toxicity in human tissues. The amount of bilirubin production is about 300 gr/day. The molecule most tightly bound to albumin is non-conjugated bilirubin: the amount of non-conjugated bilirubin not bound to albumin is < 0.1%. Non-conjugated bilirubin is currently considered as "indirect" bilirubin because it gives an indirect reaction with standard diazo reagents. Conjugated bilirubin is also bound to albumin but with a reduced affinity. The albumin-bilirubin bond occurs by means of covalent or non-covalent strengths. The 2 bilirubin binding sites on albumin show different constant of association (Ka). The primary site has a high affinity, its Ka is 55-68 micromol/L and it can bind only 1 mole of bilirubin. The secondary site has a low affinity, its Ka is 4.4-5.0 micromol/L and it can bind more than 1 mole of bilirubin. A gap between 20 and 50 ångström between albumin and the sorbent is needed to move bilirubin from albumin to the sorbent.
The CPFA efficacy on bilirubin adsorption is based on hydrophobic polystyrene-divinylbenzene copolymer matrices of the resin cartridge that have mean pore sizes of 30 nanometres. Harm et al. reported that the hydrophobic polystyrene-divinylbenzene copolymer of CPFA resin cartridge (type B copolymer: mean diameter 128 micron, pore size 30 nanometres and surface area of 700 m2/gr of resin) binds higher amount of bilirubin than the amount of bilirubin bound with the other kinds of polystyrene-divinylbenzene copolymer matrices tested (type A copolymer: mean diameter 120 micron, pore size 15 nanometres and surface area of 900 m2/gr of resin; type C copolymer: mean diameter 37 micron, pore size 100 nanometres and surface area of 200 m2/gr of resin).
Few authors in vivo assessed the bilirubin adsorbing ability of the neutral styrenic resin of CPFA. Caroleo et al. reported the first case of hepatic toxins removal by means of CPFA in a patient affected by acute liver failure due to cardiogenic shock. Maggi et al. reported 2 further cases where bilirubin removal was obtained in 2 patients with delayed graft function after liver transplantation. The patients achieved a 40% bilirubin reduction after 3 treatments with CPFA lasting 3-hours each.
- Being tested
- Coupled plasma filtration and adsorption (CPFA)
- Keywords
- CPFA, Liver failure, Resin, detoxification
- Medical subject headings
- Liver Failure, Acute, Acute-On-Chronic Liver Failure, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coupled plasma filtration and adsorption (CPFA)Device
Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a "bridge" to liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| CPFA Patients | Experimental | Patients affected by acute or acute on chronic liver failure who undergo Coupled plasma filtration and adsorption (CPFA) to recover their basal liver function or as a bridge to liver transplantation. The intervention is CPFA treatment which lasts 6 hour length. The intervention can be repeated for a maximum of 5 times. Receives: Device: Coupled plasma filtration and adsorption (CPFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mortality reduction of patients with acute or acute on chronic liver failure;
The measure is the overall survival of the patients after CPFA and standard medical therapy
Measured: 1 year
Secondary outcomes (5)
Efficacy of liver toxins detoxification
The measures of efficacy consist in the evaluation bilirubin levels, biliary acids levels, ammonia levels and lactate levels
Measured: 1 year.
Improvement of hepatic encephalopathy
The measure of hepatic encephalopathy is assessed by means of the West Haven Criteria
Measured: 1 year
Improvement of the arterial blood pressure of the patients
Measuring arterial blood pressure (mmHg) on starting CPFA, during the CPFA treatment and at CPFA end.
Measured: 1 year
Biocompatibility of CPFA
Blood leukocytes, platelets, Hemoglobin are assessed before and after each CPFA treatment
Measured: 1 year
Cytokines clearance during CPFA
Interleukin-6, Tumor Necrosis Factor alfa, Interleukin-10, Hepatocyte growth factor are assessed before and after each CPFA treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start6 Jun 2013
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Liver Failure, AcuteStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Donati, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Gaetano La Manna, Prof., Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312036
- Sponsor's protocol ID
- 87/2012/O/Disp
- Acronym
- HERCOLE
- Status last verified
- Mar 2021
- First submitted
- 28 Sep 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ronco C, Brendolan A, d'Intini V, Ricci Z, Wratten ML, Bellomo R. Coupled plasma filtration adsorption: rationale, technical development and early clinical experience. Blood Purif. 2003;21(6):409-16. doi: 10.1159/000073444.
PubMed 14586184Tetta C, Cavaillon JM, Schulze M, Ronco C, Ghezzi PM, Camussi G, Serra AM, Curti F, Lonnemann G. Removal of cytokines and activated complement components in an experimental model of continuous plasma filtration coupled with sorbent adsorption. Nephrol Dial Transplant. 1998 Jun;13(6):1458-64. doi: 10.1093/ndt/13.6.1458.
PubMed 9641176Cole L, Bellomo R, Davenport P, Tipping P, Uchino S, Tetta C, Ronco C. The effect of coupled haemofiltration and adsorption on inflammatory cytokines in an ex vivo model. Nephrol Dial Transplant. 2002 Nov;17(11):1950-6. doi: 10.1093/ndt/17.11.1950.
PubMed 12401852Ronco C, Brendolan A, Lonnemann G, Bellomo R, Piccinni P, Digito A, Dan M, Irone M, La Greca G, Inguaggiato P, Maggiore U, De Nitti C, Wratten ML, Ricci Z, Tetta C. A pilot study of coupled plasma filtration with adsorption in septic shock. Crit Care Med. 2002 Jun;30(6):1250-5. doi: 10.1097/00003246-200206000-00015.
PubMed 12072677Formica M, Olivieri C, Livigni S, Cesano G, Vallero A, Maio M, Tetta C. Hemodynamic response to coupled plasmafiltration-adsorption in human septic shock. Intensive Care Med. 2003 May;29(5):703-8. doi: 10.1007/s00134-003-1724-0. Epub 2003 Mar 29.
PubMed 12665998Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.
PubMed 15256798Lentini P, Cruz D, Nalesso F, de Cal M, Bobek I, Garzotto F, Zanella M, Brendolan A, Piccinni P, Ronco C. [A pilot study comparing pulse high volume hemofiltration (pHVHF) and coupled plasma filtration adsorption (CPFA) in septic shock patients]. G Ital Nefrol. 2009 Nov-Dec;26(6):695-703. Italian.
PubMed 19918752Mao HJ, Yu S, Yu XB, Zhang B, Zhang L, Xu XR, Wang XY, Xing CY. Effects of coupled plasma filtration adsorption on immune function of patients with multiple organ dysfunction syndrome. Int J Artif Organs. 2009 Jan;32(1):31-8. doi: 10.1177/039139880903200104.
PubMed 19241361Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
PubMed 24401721Hughes RD. Review of methods to remove protein-bound substances in liver failure. Int J Artif Organs. 2002 Oct;25(10):911-7. doi: 10.1177/039139880202501003.
PubMed 12456030Weiss JS, Gautam A, Lauff JJ, Sundberg MW, Jatlow P, Boyer JL, Seligson D. The clinical importance of a protein-bound fraction of serum bilirubin in patients with hyperbilirubinemia. N Engl J Med. 1983 Jul 21;309(3):147-50. doi: 10.1056/NEJM198307213090305.
PubMed 6866015Gong D, Cruz D, Ronco C. Depurative capacity of molecular adsorbent recycling system (MARS): A focus on bilirubin removal. Int J Artif Organs. 2008 Oct;31(10):875-81. doi: 10.1177/039139880803101003.
PubMed 19009505Harm S, Falkenhagen D, Hartmann J. Pore size--a key property for selective toxin removal in blood purification. Int J Artif Organs. 2014 Sep;37(9):668-78. doi: 10.5301/ijao.5000354. Epub 2014 Sep 23.
PubMed 25262632Caroleo S, Rubino AS, Tropea F, Bruno O, Vuoto D, Amantea B, Renzulli A. Coupled plasma filtration adsorption reduces serum bilirubine in a case of acute hypoxic hepatitis secondary to cardiogenic shock. Int J Artif Organs. 2010 Oct;33(10):749-52.
PubMed 21058270Maggi U, Nita G, Gatti S, Antonelli B, Paolo R, Como G, Messa P, Rossi G. Hyperbilirubinemia after liver transplantation: the role of coupled plasma filtration adsorption. Transplant Proc. 2013 Sep;45(7):2715-7. doi: 10.1016/j.transproceed.2013.07.019.
PubMed 24034030
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification
- ClinicalTrials.gov ID
- NCT03312036
- Acronym / sponsor ID
- HERCOLE / 87/2012/O/Disp
- Keywords
- CPFA, Liver failure, Resin, detoxification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.
Detailed description
CPFA allows an improvement of blood pressure and inflammatory response during sepsis and multiorgan failure. This extracorporeal detoxification system was developed to non-specifically remove larger mediators during systemic inflammation with an extracorporeal circuit consisting of a plasma filter, a resin cartridge and a high-flux dialyzer. At present it is performed with the use of a five-pump modular treatment consisting of a plasma filter and a following absorption on an unselective hydrophobic resin cartridge and a final passage of the reconstituted blood through a high permeability polyethersulfone haemofilter, in which convective exchanges may be applied in a postdilution mode. Ronco et al. in 2002 compared CPFA treatment to continuous veno-venous haemodiafiltration (CVVHDF) in 10 patients affected by septic shock. The patients underwent 10-hour length CPFA and an increase of arterial blood pressure and a significant reduction of norepinephrine dosage were observed in comparison to the arterial blood pressure and the norepinephrine dosage achieved with the CVVHDF treatment. Formica et al. in 2004 confirmed these results using 100 CPFA treatments in 12 patients affected by septic shock with or without acute kidney injury. Patient survival at 28 days was 90%, while survival of after 90 days was 70%. Mao et al. also compared CPFA with High Volume Hemofiltration and they showed that CPFA increased the ratio between anti-inflammatory and pro-inflammatory cytokines; CPFA enhanced Human Leucocyte Antigen (HLA) class II expression on monocytes and improved the leukocyte response to inflammation measuring leukocyte production of Tumor Necrosis Factor-alfa. Recently Livigni et al. on behalf of the Italian group for the evaluation of interventions in intensive care medicine carried out a randomised controlled trial enrolled 330 adult patients with septic shock, 192 were randomised to either have CPFA added to the standard care, or not. CPFA was to be performed daily for 5 days, lasting at least 10 h/day. The trial was stopped because nearly 50% of the patients could not achieve treatment completion due to technical reasons (primarily coagulation). The trial did observe that patients with the highest amounts of treated plasma appeared to have a survival benefit. The technique underwent further modifications to improve the technical aspects and anticoagulation and a new trial is now underway with a high dose of plasma > 0.18 litres/ kg/ day.
As to the hepatic toxin removal it depends on the ability of the detoxification system to extract albumin bound toxins by means of adsorption. The adsorption consists in the consolidation on the surface of a solid material of molecules floating in a fluid after matching the fluid with the solid. The consolidation is due to weak bounds as in the case of Van der Waals and hydrophobic bounds. The selectivity of adsorption occurs when albumin molecules easily pass throughout the sorbent while the sorbent draw the albumin carried toxins into the pores of the sorbent. The hepatic toxins often are hydrophobic and with molecular weight < 1,000 daltons (bilirubin = 406 daltons, cholic acid = 283 daltons, chenodeoxycholic acid = 272 daltons). The albumin structure consists in 3 domains, which allows a multi-binding protein transport. As to bilirubin, its protein binding is a physiological protective mechanism to prevent the free bilirubin diffusion and toxicity in human tissues. The amount of bilirubin production is about 300 gr/day. The molecule most tightly bound to albumin is non-conjugated bilirubin: the amount of non-conjugated bilirubin not bound to albumin is < 0.1%. Non-conjugated bilirubin is currently considered as "indirect" bilirubin because it gives an indirect reaction with standard diazo reagents. Conjugated bilirubin is also bound to albumin but with a reduced affinity. The albumin-bilirubin bond occurs by means of covalent or non-covalent strengths. The 2 bilirubin binding sites on albumin show different constant of association (Ka). The primary site has a high affinity, its Ka is 55-68 micromol/L and it can bind only 1 mole of bilirubin. The secondary site has a low affinity, its Ka is 4.4-5.0 micromol/L and it can bind more than 1 mole of bilirubin. A gap between 20 and 50 ångström between albumin and the sorbent is needed to move bilirubin from albumin to the sorbent.
The CPFA efficacy on bilirubin adsorption is based on hydrophobic polystyrene-divinylbenzene copolymer matrices of the resin cartridge that have mean pore sizes of 30 nanometres. Harm et al. reported that the hydrophobic polystyrene-divinylbenzene copolymer of CPFA resin cartridge (type B copolymer: mean diameter 128 micron, pore size 30 nanometres and surface area of 700 m2/gr of resin) binds higher amount of bilirubin than the amount of bilirubin bound with the other kinds of polystyrene-divinylbenzene copolymer matrices tested (type A copolymer: mean diameter 120 micron, pore size 15 nanometres and surface area of 900 m2/gr of resin; type C copolymer: mean diameter 37 micron, pore size 100 nanometres and surface area of 200 m2/gr of resin).
Few authors in vivo assessed the bilirubin adsorbing ability of the neutral styrenic resin of CPFA. Caroleo et al. reported the first case of hepatic toxins removal by means of CPFA in a patient affected by acute liver failure due to cardiogenic shock. Maggi et al. reported 2 further cases where bilirubin removal was obtained in 2 patients with delayed graft function after liver transplantation. The patients achieved a 40% bilirubin reduction after 3 treatments with CPFA lasting 3-hours each.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPFA Patients | Experimental | Device: Coupled plasma filtration and adsorption (CPFA)Patients affected by acute or acute on chronic liver failure who undergo Coupled plasma filtration and adsorption (CPFA) to recover their basal liver function or as a bridge to liver transplantation. The intervention is CPFA treatment which lasts 6 hour length. The intervention can be repeated for a maximum of 5 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute liver failure
- Acute on chronic liver failure
- Bridge to liver transplantation
Key exclusion criteria (5 listed)
- acute hemorrhage
- shock
- respiratory failure
- acute coronary syndrome
- psychiatric illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coupled plasma filtration and adsorption (CPFA)Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a "bridge" to liver transplantation | Device | CPFA Patients |
Primary outcome
The mortality reduction of patients with acute or acute on chronic liver failure;
Time frame: 1 year
The measure is the overall survival of the patients after CPFA and standard medical therapy
5 secondary outcomes
Efficacy of liver toxins detoxification
Time frame: 1 year.
Improvement of hepatic encephalopathy
Time frame: 1 year
Improvement of the arterial blood pressure of the patients
Time frame: 1 year
Biocompatibility of CPFA
Time frame: 1 year
Cytokines clearance during CPFA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 14586184Ronco C, Brendolan A, d'Intini V, Ricci Z, Wratten ML, Bellomo R. Coupled plasma filtration adsorption: rationale, technical development and early clinical experience. Blood Purif. 2003;21(6):409-16. doi: 10.1159/000073444.
- Background: PubMed 9641176Tetta C, Cavaillon JM, Schulze M, Ronco C, Ghezzi PM, Camussi G, Serra AM, Curti F, Lonnemann G. Removal of cytokines and activated complement components in an experimental model of continuous plasma filtration coupled with sorbent adsorption. Nephrol Dial Transplant. 1998 Jun;13(6):1458-64. doi: 10.1093/ndt/13.6.1458.
- Background: PubMed 12401852Cole L, Bellomo R, Davenport P, Tipping P, Uchino S, Tetta C, Ronco C. The effect of coupled haemofiltration and adsorption on inflammatory cytokines in an ex vivo model. Nephrol Dial Transplant. 2002 Nov;17(11):1950-6. doi: 10.1093/ndt/17.11.1950.
- Background: PubMed 12072677Ronco C, Brendolan A, Lonnemann G, Bellomo R, Piccinni P, Digito A, Dan M, Irone M, La Greca G, Inguaggiato P, Maggiore U, De Nitti C, Wratten ML, Ricci Z, Tetta C. A pilot study of coupled plasma filtration with adsorption in septic shock. Crit Care Med. 2002 Jun;30(6):1250-5. doi: 10.1097/00003246-200206000-00015.
- Background: PubMed 12665998Formica M, Olivieri C, Livigni S, Cesano G, Vallero A, Maio M, Tetta C. Hemodynamic response to coupled plasmafiltration-adsorption in human septic shock. Intensive Care Med. 2003 May;29(5):703-8. doi: 10.1007/s00134-003-1724-0. Epub 2003 Mar 29.
- Background: PubMed 15256798Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.
- Background: PubMed 19918752Lentini P, Cruz D, Nalesso F, de Cal M, Bobek I, Garzotto F, Zanella M, Brendolan A, Piccinni P, Ronco C. [A pilot study comparing pulse high volume hemofiltration (pHVHF) and coupled plasma filtration adsorption (CPFA) in septic shock patients]. G Ital Nefrol. 2009 Nov-Dec;26(6):695-703. Italian.
- Background: PubMed 19241361Mao HJ, Yu S, Yu XB, Zhang B, Zhang L, Xu XR, Wang XY, Xing CY. Effects of coupled plasma filtration adsorption on immune function of patients with multiple organ dysfunction syndrome. Int J Artif Organs. 2009 Jan;32(1):31-8. doi: 10.1177/039139880903200104.
- Background: PubMed 24401721Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
- Background: PubMed 12456030Hughes RD. Review of methods to remove protein-bound substances in liver failure. Int J Artif Organs. 2002 Oct;25(10):911-7. doi: 10.1177/039139880202501003.
- Background: PubMed 6866015Weiss JS, Gautam A, Lauff JJ, Sundberg MW, Jatlow P, Boyer JL, Seligson D. The clinical importance of a protein-bound fraction of serum bilirubin in patients with hyperbilirubinemia. N Engl J Med. 1983 Jul 21;309(3):147-50. doi: 10.1056/NEJM198307213090305.
- Background: PubMed 19009505Gong D, Cruz D, Ronco C. Depurative capacity of molecular adsorbent recycling system (MARS): A focus on bilirubin removal. Int J Artif Organs. 2008 Oct;31(10):875-81. doi: 10.1177/039139880803101003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano La Manna, Prof. principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coupled plasma filtration and adsorption (CPFA) in people with Liver Failure, Acute and Liver Failure, Acute on Chronic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mortality reduction of patients with acute or acute on chronic liver failure; (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312036, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.